Company
United StatesImage Diagnostics, Inc., Fitchburg, MA – FDA Inspections
Inspection records and compliance data for Image Diagnostics, Inc. in Fitchburg, Massachusetts. 4 FDA inspections on record, last inspected April 18, 2024.
Company Profile
This profile covers Image Diagnostics, Inc. based in Fitchburg, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 10, 2011. Last inspected April 18, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- DMR - not or inadequately maintained2 inspections
- Procedures not adequately established or maintained2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1236226 |
| October 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 946871 |
| August 6, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 843266 |
| March 10, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 713767 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Image Diagnostics, Inc.
FEI Number
1000305755
Address
310 Authority Dr, Fitchburg, Massachusetts 01420, United States
Country
United States
ID: 54fceb21-96a6-4b09-93b9-b40eb7d5f5f8